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Senior Manager/ Associate Director, Argus Database Administrator San Diego United States,  


Posted on : 21 March 2017

Project Description

POSITION SUMMARY: Execute and/or oversee all functions of Drug Safety Systems in meeting Drug Safety and Pharmacovigilance departmental objectives for overall compliance as outlined by the VP, Drug Safety. Management of Direct Reports as may be required. ESSENTIAL FUNCTIONS: " Lead the design, implementation and support of applications in support of Drug Safety objectives, including Argus Safety, MedDRA, etc. " Database administrator in charge of quality review of all product configuration changes to Argus " Lead the implementation of standard and ad hoc reporting process " Oversee programming, validation, and generation of reports for data analysis, including periodic reports and ICH PSUR line listings " Interpret regulatory changes as they impact technology and provide technology expertise to implement regulatory changes for maintaining compliance. " Update and review training documentation for Drug Safety SOPs related to Argus database and data management " Plan and implement MedDRA version management and upgrades as required by the Director of Drug Safety and Pharmacovigilance Department. " Manage and compile key drug safety case processing and resource requirement metrics " Act as primary liaison with IT to support delivery of computing infrastructure " Ensure compliance with relevant policies and procedures " Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies " Drive resolution of complex, cross-functional issues QUALIFICATIONS: " MS in technical field preferred; or Bachelor s Degree with requisite experience " Minimum 8 years of experience within pharmaceutical industry required, including 4 years of experience with drug safety systems and applications " Minimum 3 years of Drug Safety experience " Minimum 1 years of management experience required " Prior and recent post marketing experience in safety management and safety reporting at pharmaceutical sponsor-applicant company, is preferred. REQUIRED KNOWLEDGE AND ABILITIES:

Locations

San Diego CA United States

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